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Cardiovascular

28,927 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
CARPENTIER-EDWARDS PORCINE BIOPROSTHETIC VALVES (P870056/S041)Edwards Lifesciences, LLC2010-12-22
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHETIC VALVES (P860057/S073)Edwards Lifesciences, LLC2010-12-22
EDWARDS PRIMA PLUS PORCINE STENTLESS BIOPROSTHETIC VALVES (P010041/S025)Edwards Lifesciences, LLC2010-12-22
IMPLANTABLE PULSE GENERATOR (P890003/S208)Medtronic, Inc.2010-12-22
DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR (P820003/S103)Medtronic Cardiac Rhythm Disease Management2010-12-20
BIOCOR AND BIOCOR SUPRA VALVES (P040021/S015)ABBOTT MEDICAL2010-12-17
ARCTIC FRONT CRYOCATHETER SYSTEM (P100010)Medtronic Cryocath, LP2010-12-17
MEDTRONIC MODEL 5388 EXTERNAL PULSE GENERATOR (EPG) (P820003/S099)Medtronic Cardiac Rhythm Disease Management2010-12-16
MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM (P100021)Medtronic Vascular2010-12-16
CURRENT/PROMOTE, CURRENT ACCEL/PROMOTE ACCELL & CURRENT+/PROMOTE+FAMILIES ICDS/CRT-DS (P030054/S175)ABBOTT MEDICAL2010-12-15
RELIANCE IS -1 AND RELIANCE IS-4 (P910073/S090)Boston Scientific2010-12-15
IMPLANTABLE PULSE GENERATOR (P980035/S196)Medtronic, Inc.2010-12-15
FREEZOR CARDIAC CRYOABLATION CATHETERS, FREEZOR XTRA AND FREEZOR MAX SURGICAL CRYOABLATION DEVICES (P020045/S035)Medtronic Cryocath, LP2010-12-15
AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S015)ABBOTT MEDICAL2010-12-15
CURRENT/PROMOTE, CURRENT ACCEL/PROMOTE ACCELL & CURRENT+/PROMOTE+FAMILIES ICDS/CRT-DS (P910023/S252)ABBOTT MEDICAL2010-12-15
REPLY/ESPRIT (P950029/S055)MicroPort CRM USA, Inc.2010-12-15
AMPLATZER SEPTAL & CRIBRIFORM OCCLUDERS (P000039/S038)ABBOTT MEDICAL2010-12-15
AMPLATZER DUCT OCCLUDER (P020024/S030)ABBOTT MEDICAL2010-12-15
KAPPA 400 (P970012/S079)Medtronic, Inc.2010-12-13
350 SERIES/ADAPTA/ENPULSE/KAPPA 600/650/700/800/900/SIGMA (P980035/S195)Medtronic, Inc.2010-12-13
MARQUIS/MAXIMO (P980016/S266)Medtronic Cardiac Rhythm Disease Management2010-12-13
ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S064)Terumo Medical Corporation2010-12-10
ENDEAVOR/ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S043)Medtronic, Inc.2010-12-10
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S056)W. L. Gore & Associates, Inc.2010-12-10
IMPLANTABLE PULSE GENERATOR (P980035/S193)Medtronic, Inc.2010-12-10
THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P870072/S044)Thoratec Laboratories Corp.2010-12-09
EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS (P030054/S169)ABBOTT MEDICAL2010-12-09
CADENCE/CURRENT FAMILY OF ICDS (P910023/S249)ABBOTT MEDICAL2010-12-09
LUMAX 300/340 DR-T/LUMAX 300/400 VR-T/LUMAX 500/540 DR-T/LUMAX 500/540 VR-T/LUMAX 540 VR-T DX (P050023/S040)Biotronik, Inc.2010-12-08
ECG CABLE/CAPSURE VDD LEADS DRUG COMBINATION/SERVICE KIT PACEMAKER REPAIR KIT/PRODIGY IPG/BRILLIANT S+ VDD VITATRON LEAD (P890003/S207)Medtronic, Inc.2010-12-08
ATTAIN ABILITY LEAD DRUG COMBINATION (P080006/S018)Medtronic, Inc.2010-12-08
DISPOSABLE EPG COVER (P820003/S102)Medtronic Cardiac Rhythm Disease Management2010-12-08
CAPSURE FIX/NOVUS LEAD DRUG COMBINATION/SURE FIX/VITATRON PIROUET+/VITATRON CRYSTALINE LEAD DRUG COMBINATION (P930039/S047)Medtronic, Inc.2010-12-08
TRANSVENE CS/SVC LEAD (P980050/S056)Medtronic, Inc.2010-12-08
ADAPTA/SENSIA/VERSA/AT500/350 SERIES/ENRHYTHM/ENPULSE/KAPPA 700/800/900/RELIA/SIGMA IPGS (P980035/S194)Medtronic, Inc.2010-12-08
CAPSURE EPICARDIAL PACING LEAD DRUG COMBINATION (P950024/S027)Medtronic, Inc.2010-12-08
CLARITY /VITATRON DA+ C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+ T-SERIES/TOPAZ 3/VITA 2/VITA IPGS (P990001/S079)Medtronic, Inc.2010-12-08
MEDTRONICS ADAPTA, VERSA, SENSIA AND RELIA IMPLANTABLE PULSE GENERATOR (P980035/S150)Medtronic, Inc.2010-12-08
CAPSURE LEAD DRUG COMBINATION/MARQUIS/MAXIMO/INTRINSIC30/INTRINSIC/ENTRUST/VIRTUOSO/SECURA/VIRTUOSO II/MAXIMO II ICDS (P980016/S265)Medtronic Cardiac Rhythm Disease Management2010-12-08
PHILOS DR/DR-B/SR/SR-B/DR-T/PHILOS II DR/DR-T/SR/CYLOS DR/DR-T/VR/EVIA DR/DR-T/SR/SR-T/ENTOVIS DR/DR-T/SR/SR-T (P950037/S090)Biotronik, Inc.2010-12-08
KAPPA 400 IPG (P970012/S078)Medtronic, Inc.2010-12-08
CAPSURE /STERX TIP PACING LEAD (VENTRICULAR/CAPSURE Z/SP NOVUS/VITATRON IMPULSE/II/EXCELLENCE S+/SS+ LEAD DRUG (P850089/S072)Medtronic Cardiac Rhythm Disease Management2010-12-08
VITATRON CRYSTALINE/EXCELLENCE +/PS+/CAPSURE SP/CAPSURE SENSE/CAPSURE SP NOVUS/CAPSURE LEAD DRUG COMBINATION (P830061/S059)Medtronic Cardiac Rhythm Disease Management2010-12-08
ATTAIN STARFIX LEAD DRUG COMBINATION (P060039/S020)Medtronic, Inc.2010-12-08
STRATOS LV/LV-T (P070008/S020)Biotronik, Inc.2010-12-08
ATTAIN LEAD DRUG COMBINATION: 4193 & 4194 ONLY/INSYNC CRT-P/INSYNC III CRT-P (P010015/S104)Medtronic, Inc.2010-12-08
SELECTSECURE LEAD DRUG COMBINATION/ANCHORING SLEEVE KIT (P030036/S025)Medtronic Cardiac Rhythm Disease Management2010-12-08
LEAD ADAPTOR/IS-1 CONNECTOR PORT PIN PLUG KIT/Y ADAPTOR/EXTENDER KIT/SPRINT LEAD DRUG COMBINATION/TRANSVENE DF1/RV LEAD (P920015/S071)Medtronic, Inc.2010-12-08
TALENT CONVERTER STENT GRAFT SYSTEM AND TALENT OCCLUDER SYSTEM (P070027/S024)Medtronic Vascular2010-12-08
INSYNC II/III MARQUIS/INSYNC SENTRY/MAXIMO/II/CONCERTO/II/CONSULTA (P010031/S220)Medtronic Cardiac Rhythm Disease Management2010-12-08
ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR (P900061/S097)Medtronic Cardiac Rhythm Disease Management2010-12-08
RF /RF MARINR NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II ABLATION/RF CONTACTR CATHETERS (P930029/S028)Medtronic, Inc.2010-12-08
VISION RX/OTW/MINI VISION RX/OTW/MULTI LINK 8 RX (P020047/S027)Abbott Vascular2010-12-07
350 SERIES/ADAPTA/ENPULSE/KAPPA 600/650/700/800/900/SIGMA (P980035/S192)Medtronic, Inc.2010-12-07
LIVEWIRE CARDIAC ABLATION SYSTEM (P960016/S035)St Jude Medical2010-12-07
ZETA RX/ULTRA RX/ULTRA OTW (P970020/S059)Abbott Vascular, Inc.2010-12-07
ST JUDE MEDICAL MERLIN 3650 PROGRAMMER (P030054/S174)ABBOTT MEDICAL2010-12-07
KAPPA 400 (P970012/S077)Medtronic, Inc.2010-12-07
MARQUIS/MAXIMO (P980016/S264)Medtronic Cardiac Rhythm Disease Management2010-12-07
MEDTRONIC MODEL 5388 EXTERNAL PULSE GENERATOR (P820003/S100)Medtronic Cardiac Rhythm Disease Management2010-12-07
XIENCE V RX/PROMUS RX/XIENCE OTW/PROMUS OTW (P070015/S053)Abbott Vascular, Inc.2010-12-07
LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S036)St Jude Medical2010-12-07
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S057)W. L. Gore & Associates, Inc.2010-12-07
DURATA SJ4/DF4 FAMILIES OF HIGH VOLTAGE LEADS (P950022/S075)ABBOTT MEDICAL2010-12-06
HANCOCK APICAL LEFT VENTRICLE CONNECTOR (P870078/S011)Medtronic, Inc.2010-12-03
THERAPY COOL PATH ABLATION CATHETER (P060019/S013)Irvine Biomedical, Inc.2010-12-03
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S006)Boston Scientific Corp2010-12-03
LUMAX FAMILY OF ICDS AND CRT-DS (P050023/S038)Biotronik, Inc.2010-12-03
DRIVER & MICRO-DRIVER CORONARY STENT SYSTEM (P030009/S049)Medtronic, Ireland2010-12-01
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S052)Abbott Vascular, Inc.2010-12-01
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S053)Boston Scientific Corp2010-12-01
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S059)Medtronic, Inc.2010-12-01
STRATOS LV/LV-T CRT-P (P070008/S017)Biotronik, Inc.2010-11-26
OPTISENSE MODEL 1999 LEAD (P960013/S057)ABBOTT MEDICAL2010-11-26
EVIA/ENTOVIS DR/DR-T/SR-T & VARIOUS OTHER MODELS OF PULSE GENERATORS (P950037/S083)Biotronik, Inc.2010-11-26
BELOS/LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T, & XELOS DR-T ICDS (P000009/S040)Biotronik, Inc.2010-11-26
VARIOUS MODELS OF LUMAX ICD/CRT-D FAMILIES (P050023/S033)Biotronik, Inc.2010-11-26
GORE VIABAHN ENDOPROSTHESIS (WITH HEPARIN BIOACTIVE SURFACE) (P040037/S032)W. L. Gore & Associates, Inc.2010-11-24
GORE VIABAHN ENDOPROSTHESIS (P040037/S031)W. L. Gore & Associates, Inc.2010-11-24
DISPOSABLE EPG COVER (P820003/S101)Medtronic Cardiac Rhythm Disease Management2010-11-23
CAPSURE/STERX TIP PACING/CAPSURE Z/SP NOVUS/VITATRON IMPULSE/II/VITATRON EXCELLENCE S+/VITATRON EXCELLENCE SS+ LEAD DRUG (P850089/S071)Medtronic Cardiac Rhythm Disease Management2010-11-23
CAPSURE LEAD DRUG COMBINATION/MARQUIS/MAXIMO/INTRINSIC3/INTRINSIC/ENTRUST/VIRTUOSO/SECURA/VIRTUOSO II/MAXIMO II ICDS (P980016/S263)Medtronic Cardiac Rhythm Disease Management2010-11-23
VITATRON CRYSTALINE/VITATRON EXCELLENCE +/VITATRON EXCELLENCE PS+/CAPSURE SP/CAPSURE SENSE/CAPSURE SP NOVUS/CAPSURE LEAD (P830061/S058)Medtronic Cardiac Rhythm Disease Management2010-11-23
ATTAIN ABILITY LEAD DRUG COMBINATION (P080006/S017)Medtronic, Inc.2010-11-23
INSYNC III/II MARQUIS CRT-D/INSYNC SENTRY/MAXIMO CRT-D/CONCERTO/CONSULTA/CONCERTO II/MAXIMO II CRT-D (P010031/S219)Medtronic Cardiac Rhythm Disease Management2010-11-23
ADAPTA/SENSIA/VERSA/AT500/350 SERIES/ENRHYTHM/ENPULSE/KAPPA 700/800/900/RELIA/SIGMA IPGS (P980035/S191)Medtronic, Inc.2010-11-23
CAPSURE FIX/NOVUS/SUREFIX/VITATRON PIROUET+/VITATRON CRYSTALINE LEAD DRUG COMBINATIONS (P930039/S046)Medtronic, Inc.2010-11-23
CLARITY/VITATRON DA+C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+T-SERIES/TOPAZ 3/VITA 2/VITA IPGS (P990001/S078)Medtronic, Inc.2010-11-23
CAPSURE EPICARDIAL PACING LEAD DRUG COMBINATION (P950024/S026)Medtronic, Inc.2010-11-23
RF MARINR/NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II ABLATION/RF CONTACTR/CONDUCTR SELF-REF/ATAKR II (P930029/S027)Medtronic, Inc.2010-11-23
SELECTSECURE LEAD DRUG COMBINATION/ANCHORING SLEEVE KIT (P030036/S024)Medtronic Cardiac Rhythm Disease Management2010-11-23
TRANSVENE CS/SVC LEAD (P980050/S055)Medtronic, Inc.2010-11-23
KAPPA 400 IPG (P970012/S076)Medtronic, Inc.2010-11-23
ATTAIN STARFIX LEAD DRUG COMBINATION (P060039/S019)Medtronic, Inc.2010-11-23
ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR/ACCESSORY (UPSIZING SLEEVE) (P900061/S096)Medtronic Cardiac Rhythm Disease Management2010-11-23
ECG CABLE/CAPSURE VDD LEADS DRUG COMBINATION/SERVICE KIT PACEMAKER REPAIR KIT/PRODIGY IPG/BRILLIANT S+ VDD VITATRON LEAD (P890003/S206)Medtronic, Inc.2010-11-23
ATTAIN LEAD DRUG COMBINATION 4193 & 4194/INSYNC CRT-P/INSYNC III CRT-P (P010015/S103)Medtronic, Inc.2010-11-23
SPRINT LEAD/TRANSVENE DF1/RV LEAD/SPRINT QUATTRO/TRANSVENE SVC/CS/SUBCUTANEOUS/TUNNELING TOOL/TRANSVENE SUBQ LEADS (P920015/S070)Medtronic, Inc.2010-11-23
HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT MODEL 150 (P790007/S028)Medtronic Heart Valves2010-11-19
MODEL 8005 CIRCUCOOL PUMP (P980003/S026)Boston Scientific Corp2010-11-19
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